MyoMotion

GUDID 00816271020285

Clinical Sensor

Noraxon U.S.A., Inc.

Kinesiology/electromyographic sensor set

• Primary Device ID: 00816271020285
• NIH Device Record Key: e3b2f24b-ed64-4c34-a9d0-7cba28288900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoMotion
• Version Model Number: 616
• Company DUNS: 611243809
• Company Name: Noraxon U.S.A., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 4804433413
• Email: support@noraxon.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816271020285 [Primary]

FDA Product Code

• KQX: Goniometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-29
• Device Publish Date: 2019-11-21

On-Brand Devices [MyoMotion]

• 00816271020308: MyoMotion Clinical Receiver
• 00816271020285: Clinical Sensor
• 00816271020261: MyoMotion Sensor Charging Station
• 00816271020254: MyoMotion Research Pro Receiver
• 00816271020247: Research Sensor